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Endo Stitch
Model 173016 · Covidien LP · DI 10884521100008
OCW — Endoscopic Tissue Approximation Device · Class II · 21 CFR 876.1500
UDILibrary device dossier · generated 2026-09-13 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (868)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
Malfunction: 632 · Injury: 235 · Death: 1
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
13
4.33
2019-02
15
5.22
2019-03
25
5.13
2019-04
17
5.93
2019-05
17
5.62
2019-06
13
4.83
2019-07
23
5.82
2019-08
10
3.1
2019-09
11
3.7
2019-10
8
4.36
2019-11
9
3.78
2019-12
17
5.45
2020-01
8
4.56
2020-02
4
2.78
2020-03
15
4.5
2020-04
6
3.1
2020-05
1
2
2020-06
6
2.44
2020-07
12
3.77
2020-08
6
2.3
2020-09
9
4.22
2020-10
21
4.55
2020-11
10
4.6
2020-12
8
3.54
2021-01
11
3.67
2021-02
5
3.25
2021-03
13
4
2021-04
10
3.77
2021-05
10
2.92
2021-06
22
4.33
2021-07
11
2.92
2021-08
8
4.17
2021-09
15
3.43
2021-10
9
2.91
2021-11
5
3.36
2021-12
9
3.75
2022-01
6
4
2022-02
9
4.33
2022-03
6
3.4
2022-04
15
3.27
2022-05
22
6.4
2022-06
41
6.67
2022-07
18
5
2022-08
22
4.67
2022-09
17
2.93
2022-10
11
3.82
2022-11
5
3.18
2022-12
7
2.83
2023-01
9
3.67
2023-02
7
3.5
2023-03
8
3.69
2023-04
5
3.55
2023-05
11
3.39
2023-06
4
2.68
2023-07
14
3.75
2023-08
8
3.25
2023-09
7
3.07
2023-10
8
5.38
2023-11
7
3.22
2023-12
5
4.73
2024-01
8
4.55
2024-02
13
3.22
2024-03
8
2.73
2024-04
2
3.75
2024-05
2
2.14
2024-06
9
3.54
2024-07
2
2.58
2024-08
7
2.71
2024-09
8
3.21
2024-10
5
3.6
2024-11
2
3.43
2024-12
3
1.8
2025-01
17
5
2025-02
4
4.15
2025-03
8
4.33
2025-04
7
4.22
2025-05
5
4.45
2025-06
13
4.65
2025-07
7
5.56
2025-08
10
4.33
2025-09
2
2.5
2025-10
4
3.13
2025-11
5
4.64
2025-12
5
6.5
2026-01
0
4.29
2026-02
7
4.42
2026-03
8
5.57
2026-04
4
7.07
2026-05
3
11.14
2026-06
6
7.69
This device (reports/month)Average device in OCW (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K934738 — cited as predicate by K111442
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Covidien LP
Warning Letter 2012-06-14 Covidien, LP
Warning Letter 2012-06-14 Covidien, LP
Warning Letter 2011-10-04 Oridion Medical 1987 Ltd.